Magnesium Sulfate for Bronchiolitis

Overseen By Janice Sullivan, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Louisville

Disqualifiers: Chronic lung disease, congenital heart disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 20 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether magnesium sulfate can improve breathing in infants with moderate to severe bronchiolitis, a lung condition that causes breathing difficulties. Participants will receive either magnesium sulfate or a placebo to evaluate its effectiveness and safety. Infants under 12 months old admitted to the pediatric intensive care unit with bronchiolitis are suitable candidates for this study. As a Phase 2, Phase 3 trial, this research assesses the treatment's effectiveness in an initial group and represents the final step before FDA approval, offering a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that magnesium sulfate might help treat bronchiolitis, a lung condition common in children. Some studies suggest it could help clear blocked airways. However, more evidence is needed to confirm its safety and effectiveness for this use.

One study found that children who received magnesium sulfate had a higher chance of needing to return to the hospital within 30 days. Conversely, another study suggests it is generally a safe and affordable option. Early results from another group of children showed that magnesium sulfate is usually safe and well-tolerated.

In summary, while there are promising signs, further research is necessary to confirm the safety of magnesium sulfate for treating bronchiolitis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for bronchiolitis, such as supportive care and bronchodilators, Magnesium Sulfate offers a unique approach by acting as a bronchodilator with anti-inflammatory properties. Researchers are excited about this treatment because it can relax the muscles around the airways and reduce inflammation, which could ease breathing in affected patients. Additionally, Magnesium Sulfate is administered as a quick-acting bolus over just twenty minutes, potentially providing faster relief than some current options.

What evidence suggests that magnesium sulfate might be an effective treatment for bronchiolitis?

This trial will compare Magnesium Sulfate with a placebo to evaluate its effectiveness in treating bronchiolitis. Research has shown that the effectiveness of magnesium sulfate for this condition remains unclear. One study found that administering magnesium sulfate through an IV did not benefit patients with sudden bronchiolitis and might even be harmful. However, another study found that children with moderate bronchiolitis improved when treated with magnesium sulfate through a nebulizer. Overall, the evidence is mixed, and further research is needed to determine if this treatment is truly effective for bronchiolitis. ^{1 3 6 7 8}

Who Is on the Research Team?

John W Berkenbosch, MD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for infants under 12 months old with moderate to severe bronchiolitis, admitted to the pediatric intensive care unit within the last 24 hours. Parents must consent for their child's participation. Infants with cyanotic heart disease, chronic lung disease, or unrepaired congenital heart disease cannot participate.

Inclusion Criteria

I was admitted to the Pediatric Intensive Care Unit less than 24 hours ago.

Parent/LAR consents for infant to participate

You have moderate to severe bronchiolitis based on a specific scoring system.

Exclusion Criteria

I have a heart condition from birth that hasn't been fixed.

I have a long-term lung condition.

I have a heart condition that causes bluish skin from poor circulation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a bolus of 50mg/kg Magnesium Sulfate or placebo over twenty minutes

20 minutes

1 visit (in-person)

Monitoring

Participants are monitored for vital signs and MPIS for six hours post-treatment

6 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium Sulfate

Trial Overview The study tests how a single dose of magnesium sulfate affects infants with bronchiolitis in terms of breathing and overall respiratory health. It also looks at any side effects and safety concerns associated with this treatment.

How Is the Trial Designed?

Group I: Magnesium Sulfate Experimental Treatment 1 Intervention

The patient will receive a bolus of 50mg/kg MgSO4 over twenty minutes.

Group II: Placebo Placebo Group 1 Intervention

The patient will receive a bolus of Normal Saline over twenty minutes.

Magnesium Sulfate is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment
• Constipation treatment

Approved in European Union as Magnesium sulphate for:

• Pre-eclampsia and eclampsia treatment
• Hypomagnesemia treatment

Approved in Canada as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Published Research Related to This Trial

In a study of 54 children with moderate to severe asthma exacerbations, the administration of high-dose magnesium sulfate did not significantly improve asthma symptoms compared to a placebo, as measured by Pulmonary Index scores.

There was no notable difference in hospitalization rates or time to meet discharge criteria between the magnesium and placebo groups, indicating that magnesium sulfate may not be an effective routine treatment for acute asthma in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of magnesium in the emergency department treatment of children with asthma. Scarfone, RJ., Loiselle, JM., Joffe, MD., et al.[2006]

A review of 16 studies indicates that intravenous bolus magnesium sulphate is safe for treating children with acute severe asthma in non-critical care settings.

Safety measures, such as line of sight nursing and cardiorespiratory monitoring, are essential when administering magnesium sulphate to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is intravenous magnesium sulphate safe to be administered outside the critical care setting? de Havilland, A., Hariharan, G., Puvvadi, R.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8139137/

Magnesium sulphate for treating acute bronchiolitis in children ... There is insufficient evidence to establish the efficacy and safety of magnesium sulphate for treating children up to two years of age with acute bronchiolitis.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28286262/

IV Magnesium Sulfate for Bronchiolitis: A Randomized Trial Conclusions: IV magnesium did not provide benefit for patients with acute bronchiolitis and may be harmful. Trial registry: ClinicalTrials.gov; No.: NCT02145520 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06955559

Magnesium Sulfate in Bronchial Asthma and Acute ... This combination of efficacy, few side effects, wide availability, and low cost suggest that magnesium sulphate is a promising therapeutic agent that deserves ...

4. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012965.pub2/full

Magnesium sulphate for treating acute bronchiolitis in ... There is insufficient evidence to establish the efficacy and safety of magnesium sulphate for treating children up to two years of age with acute bronchiolitis.

5. journals.lww.com journals.lww.com/jpcr/fulltext/2022/09030/efficacy_of_nebulized_magnesium_sulfate_in.7.aspx

Efficacy of nebulized magnesium sulfate in moderate... Conclusions: Children with moderate bronchiolitis were improved with nebulized magnesium sulfate. INTRODUCTION. Bronchiolitis is the most common disease of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6491316/

Magnesium sulphate for acute bronchiolitis in children under ... Magnesium sulphate may offer a safe, widely available, and low‐cost therapy to relieve airway obstruction in children with bronchiolitis.

7. cochrane.org cochrane.org/evidence/CD012965_magnesium-sulphate-treating-children-two-years-old-bronchiolitis

Magnesium sulphate for treating children up to two years ... There is insufficient evidence to establish the efficacy and safety of magnesium sulphate for treating children up to two years of age with acute bronchiolitis.

8. cureus.com cureus.com/articles/408737-magnesium-sulfate-in-pediatric-emergency-medicine-pharmacology-evidence-and-clinical-applications.pdf

Magnesium Sulfate in Pediatric Emergency Medicine Preliminary results from 43 enrolled children demonstrate excellent safety profiles and provide valuable pharmacokinetic data to guide future ...